Reported Reactions

Adverse event reports that FDA received

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Intervertebral disc protrusion adverse event reports that record this term

Kind of term
MedDRA preferred term
Plain meaning
a bulging spinal disc

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.

Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on . The data have the reports that FDA received through .

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on .

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Reports on file

From January 2004 to June 2026, FDA received 21,537 adverse event reports that record the MedDRA preferred term Intervertebral disc protrusion. In plain words, the term means: a bulging spinal disc. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 787 reports in the 12 months to June 2026 and 896 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

By reports in the 12 months to June 2026, this term was number 732 of 1,436 reaction terms with a page. Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 787 (0.1%) record this term. Reports for female patients were 66% of the reports that record this term and 52.7% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate.

MedDRA

The Medical Dictionary for Regulatory Activities. The person who codes a report selects the preferred term that agrees best with the description of the reporter. FDA does not publish the description.

Plain meaning

A bulging spinal disc. The words are from the fixed dictionary of this site. They add nothing to a report.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Drugs in these reports

The table has the 110 drug pages with 50 or more reports that record this term. The rows are in order of name. A drug page with fewer reports for this term is not in the table. The counts are the counts that the site keeps for each reaction term, and a count can be lower than the count of FDA.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.

Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of . The site read the page on .

Drugs that the reports with the term Intervertebral disc protrusion name as a suspect product, in order of name
DrugClassReports with this term
AbataceptSelective T cell costimulation modulator120
Aclasta50
ActemraInterleukin-6 receptor antagonist181
ActonelBisphosphonate51
AdalimumabTumor necrosis factor blocker74
Albuterol sulfatebeta2-Adrenergic agonist69
Alendronate sodiumBisphosphonate235
AmlodipineCalcium channel blocker51
AmpyraPotassium channel blocker105
AravaAntirheumatic agent71
Aredia234
Atorvastatin64
AubagioPyrimidine synthesis inhibitor106
AvonexInterferon beta810
Boniva90
CelebrexNonsteroidal anti-inflammatory drug223
Certolizumab pegolTumor necrosis factor blocker88
CimziaTumor necrosis factor blocker64
CiprofloxacinFluoroquinolone antibacterial55
ClonazepamBenzodiazepine63
CortisoneCorticosteroid65
CosentyxInterleukin-17A antagonist255
CrestorHMG-CoA reductase inhibitor100
Cymbalta95
DexamethasoneCorticosteroid64
DilaudidOpioid agonist72
DupixentInterleukin-4 receptor alpha antagonist148
Duragesic-100103
EliquisFactor Xa inhibitor70
EnbrelTumor necrosis factor blocker1,143
EntrestoAngiotensin 2 receptor blocker53
Erelzi84
EtanerceptTumor necrosis factor blocker77
FentanylOpioid agonist58
ForteoParathyroid hormone analog200
FosamaxBisphosphonate606
Fosamax Plus D126
GabapentinAnti-epileptic agent164
GilenyaSphingosine 1-phosphate receptor modulator178
HumalogInsulin analog116
Humira3,162
HydrochlorothiazideThiazide diuretic53
HydroxychloroquineAntimalarial50
IbranceKinase inhibitor51
IbuprofenNonsteroidal anti-inflammatory drug109
ImbruvicaKinase inhibitor55
InflectraTumor necrosis factor blocker82
InfliximabTumor necrosis factor blocker116
KesimptaCD20-directed cytolytic antibody72
LantusInsulin analog54
LeflunomideAntirheumatic agent87
LipitorHMG-CoA reductase inhibitor107
Lyrica578
Mabthera57
MetforminBiguanide73
MethotrexateFolate analog metabolic inhibitor561
Methotrexate sodiumFolate analog metabolic inhibitor122
Morphine sulfateOpioid agonist59
Neurontin118
NexiumProton pump inhibitor322
NuvaringEstrogen50
OcrevusCD20-directed cytolytic antibody205
OmalizumabAnti-IgE80
OmeprazoleProton pump inhibitor75
OrenciaSelective T cell costimulation modulator142
OtezlaPhosphodiesterase 4 inhibitor74
Oxycodone hydrochlorideOpioid agonist124
OxyContinOpioid agonist143
PantoprazoleProton pump inhibitor78
PercocetOpioid agonist57
PlaquenilAntimalarial77
PrednisoloneCorticosteroid50
PrednisoneCorticosteroid302
Pregabalin81
PrilosecProton pump inhibitor73
ProliaRANK ligand inhibitor196
RebifInterferon beta316
RemicadeTumor necrosis factor blocker248
RepathaPCSK9 inhibitor84
RevlimidThalidomide analog165
RinvoqJanus kinase inhibitor454
RituxanCD20-directed cytolytic antibody53
RituximabCD20-directed cytolytic antibody171
Sandostatin LAR Depot79
SeroquelAtypical antipsychotic119
SimponiTumor necrosis factor blocker187
SingulairLeukotriene receptor antagonist50
SkyriziInterleukin-23 antagonist244
SuboxoneOpioid antagonist59
SulfasalazineAminosalicylate85
SymbicortCorticosteroid56
Synthroidl-Thyroxine55
TasignaKinase inhibitor60
Tecfidera229
TeriflunomidePyrimidine synthesis inhibitor66
Tiotropium bromideAnticholinergic106
TocilizumabInterleukin-6 receptor antagonist66
Tramadol74
Tramadol hydrochlorideOpioid agonist71
TruvadaHuman immunodeficiency virus nucleoside analog reverse transcriptase inhibitor53
TysabriIntegrin receptor antagonist622
VedolizumabIntegrin receptor antagonist119
Vioxx291
XeljanzJanus kinase inhibitor386
XolairAnti-IgE108
XyremCentral nervous system depressant478
XywavCentral nervous system depressant60
ZoloftSerotonin reuptake inhibitor51
Zometa361
Zopiclone54

The page of each drug has the count of each reaction term in its reaction lookup.

Drug classes in these reports

The table has the 42 pharmacologic classes with 100 or more reports that record this term. The rows are in order of name.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.

Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of . The site read the page on .

Pharmacologic classes of the drugs that the reports with the term Intervertebral disc protrusion name, in order of name
ClassReports with this term
Angiotensin 2 receptor blocker239
Anti-epileptic agent219
Anti-IgE188
Anticholinergic118
Antimalarial147
Antirheumatic agent158
Atypical antipsychotic260
Benzodiazepine208
beta-Adrenergic blocker118
beta2-Adrenergic agonist128
Bisphosphonate921
CD20-directed cytolytic antibody535
Central nervous system depressant543
Corticosteroid692
Endothelin receptor antagonist104
Factor Xa inhibitor131
Folate analog metabolic inhibitor687
GLP-1 receptor agonist178
HMG-CoA reductase inhibitor328
Insulin analog323
Integrin receptor antagonist766
Interferon beta1,198
Interleukin-17A antagonist310
Interleukin-23 antagonist270
Interleukin-4 receptor alpha antagonist156
Interleukin-6 receptor antagonist262
Janus kinase inhibitor962
Kinase inhibitor408
Nonsteroidal anti-inflammatory drug604
Opioid agonist1,024
Parathyroid hormone analog204
Phosphodiesterase 4 inhibitor107
Potassium channel blocker130
Proton pump inhibitor650
Pyrimidine synthesis inhibitor172
RANK ligand inhibitor233
Selective T cell costimulation modulator262
Serotonin and norepinephrine reuptake inhibitor116
Serotonin reuptake inhibitor126
Sphingosine 1-phosphate receptor modulator194
Thalidomide analog208
Tumor necrosis factor blocker2,094

A class with many reports in all has many reports for almost every term.

Reports by month

Reports that record Intervertebral disc protrusion, by month, five years to June 2026
010020020222023202420252026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Patients in these reports

Age of the patient in the reports that record Intervertebral disc protrusion
AgeReportsShareShare as a bar
Under 24under 0.1%
2 to 11140.1%
12 to 17330.2%
18 to 442,54011.8%
45 to 646,97132.4%
65 to 742,53411.8%
75 and over1,0374.8%
Age not given8,40439%
Sex of the patient in the reports that record Intervertebral disc protrusion
SexReportsShareShare as a bar
Female14,21466%
Male6,36629.6%
Unknown or not given9574.4%

Age and sex are as the report gives them. 66.5% of these reports give the United States as the country.

Terms near this one

Official pages

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Reported Reactions. Intervertebral disc protrusion: adverse event reports that record this term. https://reportedreactions.com/reaction/intervertebral-disc-protrusion/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of . Reports received through .

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

The count has the reports with each spelling of one MedDRA preferred term. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

What does Intervertebral disc protrusion mean in an adverse event report?

In plain words: a bulging spinal disc. It is a MedDRA preferred term. FDA codes the description of a reporter with the MedDRA dictionary. The openFDA files do not have the description itself, and this site does not show it.

Does a drug in the table mean that the drug was responsible for this reaction?

No. FDA says:

No individual drug is connected to any individual reaction.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

What does this page tell a person who has this symptom?

This page gives counts of reports. It cannot assess a person. A pharmacist or a clinician can assess a person.

If this is a medical emergency, please call 911.

Source: FDA, MedWatch Online Voluntary Reporting Form. The site read the page on .